Quality Control Lab Technician (Pharmaceutical)

POSITION SUMMARY

Laboratory Technician position is responsible for sampling raw materials and laboratory activities including, but not limited to, raw material testing, bulk/finished product testing, data validation, tracking and trend analysis. Laboratory Technician is expected to be able to perform tasks related to being on shift to support production needs and analytical laboratory analysis.

ESSENTIAL DUTIES AND RESPONSIBILITIES

The essential functions include, but are not limited to the following:

· Must understand and adhere to the 21 CFR 211, 21 CFR 820, Good Documentation Practices (GDocP), and Good Laboratory Practices (GLP) outlined in company policies and/or regulatory standards

· Must follow and comply with company safety protocols and procedures while working in a safe manner

· Proficient in laboratory procedures and systems, documentation procedures, equipment operations and calibrations.

· Monitor and run a stability test of developmental prototypes and manufactured finished products.

· Prepare R&D and samples to send to independent labs for PET, active ingredients and track data results

· Responsible for product sampling and analysis according to approved procedures (physical, chemical, and microbial) per the product specification.

· Maintain effective communication with contract testing laboratories and provide status updates for raw materials, bulk, and finished products.

· Perform in-house testing for identification of raw materials via Fourier-transform Infrared Spectroscopy (FT-IR)

· Perform physical testing using pH meter, pycnometer, and viscometer.

· Organize and order inventory and maintain a neat workspace

· Prepare master test reports with required testing and specifications for all in-bound raw materials for the Quality Manager’s review and approval.

· Oversee and monitor the DI water system weekly and report any non-conformances.

· Initiate and draft non-conformance, deviations, document change control reports.

MINIMUM QUALIFICATIONS (KNOWLEDGE, SKILLS, AND ABILITIES)

· Understand the job specific quality system procedures and processes as defined and adhere to the requirements listed in those documents.

· Quantitative skills and knowledge of math functions such as percentages and decimals.

· Knowledge and prior experience with pH, viscometer, FT-IR, and pycnometer

EDUCATION, TRAINING AND EXPERIENCE

· Bachelor’s or associate degree in science field, preferred

· Education may be substituted for two or more years of experience in a laboratory setting

PAY & SCHEDULE

· $19 an hour

· Non-Except

· Full-time, In-Office.

· Monday – Friday, 7:30am – 4:00pm.

PHYSICAL DEMANDS AND WORK ENVIRONMENT

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform the functions. While performing the duties of this position, the employee is regularly required to talk or hear. The employee frequently is required to use hands or fingers, handle or feel objects, tools, or controls. The employee is occasionally required to stand, walk; sit; and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this position include close vision, distance vision, and the ability to adjust focus. The noise level in the work environment is usually low to moderate.

Job Type: Full-time

Pay: $19.00 per hour

Expected hours: 40 per week

Benefits:

401(k)
401(k) matching
Dental insurance
Health insurance
Life insurance
Paid time off
Retirement plan
Vision insurance
Work Location: In person